The purpose of this study is to find out whether a protein, called mesothelin, found in the blood and tissue can be used as "marker" for esophageal cancer. Doctors at Memorial Sloan-Kettering Cancer Center would like to compare levels of this protein in patients with abnormal cells or tissue of the esophageal to the levels of this protein in patients being treated for cancer for the esophagus.
Study Type
OBSERVATIONAL
Enrollment
371
Tissue mesothelin staining at the time of the initial endoscopy, and of any subsequent biopsy specimen during the endoscopic screening period. Serum mesothelin level at the time of initial endoscopy, and at each subsequent endoscopy for two years or until disease recurs.
Tissue mesothelin staining on the surgically resected esophageal specimen. Serum mesothelin level at the time of surgical resection, and at each follow-up clinic visit for two years or until disease recurs.
Tissue mesothelin staining on the initial endoscopic specimen (typically obtained when an EUS is done) and on the surgically resected esophageal specimen Serum mesothelin level prior to initiation of induction chemotherapy, at the time of the post-induction PET, at the time of surgical resection, and at each follow-up clinic visit for two years or until disease recurs.
Memorial Sloan Kettering Cancer Center
New York, New York, United States
To evaluate prospectively what proportion of esophageal adenocarcinomas express tissue.
The investigators will examine the range and variability in the percentage on cells stained (for TM) and in the absolute value (for SM). TM expression is commonly analyzed in a binary fashion, with 25% of cells stained indicating positive expression (per standard pathological guidelines for tissue staining)
Time frame: 2 years
To evaluate prospectively if serum mesothelin levels correlate to clinical stage in esophageal adenocarcinomas
The investigators will explore the optimal cut point that defines positive expression. Serum mesothelin (SM) will be measured and analyzed whenever possible on a continuous scale.
Time frame: 2 years
To evaluate prospectively if clinical response to induction chemotherapy
First, the investigators will use two-sample t-tests to determine whether the initial responders to induction chemotherapy (defined as \>30% decrease in SUV at the repeat PET) differ from non-responders in their 1) baseline (pre-induction) SM value, and 2) percent change in SM value between pre-induction and mid-induction (after 2 cycles) evaluations.
Time frame: 2 years
To evaluate prospectively if clinical response to concurrent chemo-radiation correlates to serum mesothelin levels
The investigators will take the following steps in order to assess the ability of SM at the time of resection with curative intent to predict disease recurrence: 1) we will examine the association between SM and the risk of recurrence by fitting a Cox proportional hazards model (after appropriate transformation of the SM value and checking of the PH assumption
Time frame: 2 years
To evaluate whether expression of tissue mesothelin is a predictor of recurrence
The investigators will Wilcoxon test to investigate the association between serum mesothelin and tissue mesothelin at each time point where both markers are evaluated, and will further attempt to obtain an aggregate measure of this correlation using clustered Wilcoxon test, which accounts for multiple measurements per patient (14).
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Time frame: 2 years
To evaluate whether expression of tissue mesothelin is a predictor of poor response to chemotherapy
Mesothelin positive tumors (MES+) will be defined as strong staining in \> 25% of the tumor cells and mesothelin negative tumors (MES-) are defined as \<= 25% cytoplasmic staining. Serum mesothelin will be collected and analyzed, whenever possible, on a continuous scale.
Time frame: 2 years
To evaluate for the presence of any confounders in the putative association between serum mesothelin expression and the risk of recurrence
Time frame: 2 years
To evaluate the correlation between serum mesothelin levels and tissue expression
Time frame: 2 years